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Basaglar Approval History

  • FDA approved: Yes (First approved December 16th, 2015)
  • Brand name: Basaglar
  • Generic name: insulin glargine
  • Dosage form: Injection
  • Company: Eli Lilly and Company and Boehringer Ingelheim
  • Treatment for: Diabetes, Type 1, Diabetes, Type 2

Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus.

Basaglar is similar to Lantus (insulin glargine injection) though it is not approved as a biosimilar product. Basaglar was approved through an abbreviated approval pathway that included data from two Basaglar-specific clinical trials, and additional evidence that demonstrated Basaglar was sufficiently similar to Lantus to justify its safety and effectiveness.

Basaglar is administered by subcutaneous injection once daily at the same time each day.

The most common side effects reported during clinical trials included hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema, and weight gain.

Development History and FDA Approval Process for Basaglar

Dec 17, 2015Approval FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes

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